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Keryx Biopharmaceuticals Announces Issuance of a New U.S. Patent for Ferric Citrate Covering Orally Administrable Forms

NEW YORK, Oct. 1, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 8,846,976. The patent, which expires in 2024, claims a method of treating hyperphosphatemia comprised of administering a therapeutically effective amount of an orally administrable form of Ferric Citrate to a subject, wherein the orally administrable form is prepared from a ferric citrate active pharmaceutical ingredient having an intrinsic dissolution rate of at least 1.88/mg/cm2/min. In addition, U.S. Patent No. 8,846,976 contains claims directed to the FDA approved dosing and daily administration of Ferric Citrate.

On September 5, 2014, Ferric Citrate was approved by the U.S. Food and Drug Administration for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

This newly issued patent further enhances the Company's key patent family, which includes U.S. Patent Nos. 7,767,851, 8,299,298, 8,338,642, 8,609,896, 8,754,257 and 8,754,258, which expire in 2024, and U.S. Patent No. 8,093,423, which expires in 2028, before patent term extension. Each of these patents contains composition and method of use claims covering Ferric Citrate.

Ron Bentsur, Chief Executive Officer of Keryx, commented, "The patent that issued today is significant in that it links orally administrable forms of Ferric Citrate prepared from Keryx's API having an intrinsic dissolution rate of at least 1.88/mg/cm2/min with a method of treatment consistent with the therapeutic claim in the package insert. Moreover, the timing of issuance, which is merely 3 months after the issuance of U.S. Patent Nos. 8,754,257 and 8,754,258 last June, provides substantiating evidence of our rapidly growing patent portfolio."

The Company continues to prosecute additional patent applications for Ferric Citrate, which, if issued, would expand the scope of patent claims covering Ferric Citrate beyond 2030.

In the coming weeks, the Company plans to file for Patent Term Extension, which, if granted, would add up to an additional 5 years to the patent protection for Ferric Citrate. Importantly, following FDA approval, the FDA Substance Registration System adopted tetraferric tricitrate decahydrate as the name of the active ingredient approved for marketing by the FDA, to appropriately describe the Company's proprietary form of ferric citrate.

Mr. Bentsur added, "The novelty of our active ingredient is important because Patent Term Extension is granted for a drug if the drug's active ingredient has not been previously approved by the FDA." Mr. Bentsur added, "To our knowledge, no other approved drugs contain tetraferric tricitrate decahydrate as the active ingredient."

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients with renal disease. Keryx plans to commercially launch Ferric Citrate in the U.S. in the fourth quarter of 2014. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.

For additional company information, including full prescribing information for Ferric Citrate, please visit www.keryx.com.

Cautionary Statement

Some of the statements included in this press release particularly those regarding Keryx's additional patent applications that may cover Ferric Citrate, and the ability to obtain patent term extension, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially include the fact that the U.S. Patent and Trademark Office, or other similar foreign patent authorities, may not issue those patents or grant a patent term extension and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT: KERYX CONTACT: Amy Sullivan Vice President - Corporate Development and Public Affairs Keryx Biopharmaceuticals, Inc. Tel: 617.466.3447 E-mail: amy.sullivan@keryx.com

Source:Keryx Biopharmaceuticals, Inc.